Greenberg Traurig and Intertox Present Report on Nanotechnology, Health and the Environment

From our press release:

The beneficial effects of nanotechnology innovation on human health and the environment are the focus of a comprehensive report to be presented at the Nano Science and Technology Institute’s Nanotech Conference and Expo 2010 in Anaheim, CA, June 21-24, 2010....Nanotechnology may substantially improve the quality of both human life and the natural environment, according to the authors of the report: Chinh H. Pham, Chair of Greenberg Traurig’s Nanotechnology Practice; Reed D. Rubinstein, Shareholder in the Environmental and Administrative Law Practice at Greenberg Traurig in Washington, D.C.; Dr. Richard C. Pleus, Managing Director of Intertox; and Lynn Foster, CEO of BPT Pharmaceuticals, who was previously at Greenberg Traurig. The EHS risks of nanotechnology require additional study. However, initial indications are that these risks are generally remote, speculative, and manageable, according to the report. It is now available for download at Nanotechnology - Greenberg Traurig, LLP.

This is a good report. Go read it.

 

NNI Does Nanotech EHS Regulation Right.

The NNI's Third Report is out.  The environmental, health, and safety section calls for interagency coordination and identification of "plausible risks."    This is good policy and good science.  So why isn't EPA listening?  

The NNI's approach to EHS emphasizes cooperation, coordination, and, most critically, risk assessment focused on plausible, not theoretical, concerns.   It states: 

Over the past two years, the NNI has released a cross-agency nanotechnology EHS research strategy, instigated multi-stakeholder workshops on nanotechnology EHS issues, and seen the Federal nanotechnology EHS research budget increase from $67.9 million in 2008 to a requested $116.9 million in 2011.  Individual agencies have also played an active role in international efforts to develop nanotechnology responsibly....NNAP recommends that member agencies increase coordinated efforts...Specifically, the NSET Subcommittee’s interagency working group on Nanotechnology, Environmental, and Health Implications (NEHI) should develop clear principles to support the identification of plausible risks associated with the products of nanotechnology. The NSET Subcommittee’s NEHI working group should also further develop and implement a cross-agency strategic plan that links EHS research activities with knowledge gaps and decision-making needs within government and industry to make commercial and regulatory decisions that ensure safe use of nanotechnology products.

EPA, by contrast, seems to have determined to stretch its legal authorities, to act unilaterally, and to regulate highly theoretical risks.    In this case, NNI, not EPA, has it right.   NNI's approach will facilitate nanotechnology research and deployment.  EPA's approach will not.       

What Is EPA Doing? The Assault On Nanotechnology Continues

EPA’s assault against nanotechnology seems to be getting serious.  The minutes of a recent EPA Scientific Advisory Panel (SAP) review of silver nanomaterials, commonly used due to their anti-microbial affect, seem to indicate EPA intends to slow down or even stop commercial use of this product. The SAP review comes against the backdrop of an ongoing campaign by anti-technology pressure groups to stop the use of silver and other nanomaterials. 

However, given the absence of evidence that these materials pose any meaningful human health or environmental risk, EPA's actions are difficult to understand.  To begin with, the SAP conceded an absence of data suggesting silver ions from silver nanomaterials behave differently than silver ions from any other source.  Yet, it assumed without data the rate of silver ion production, as well as the distribution of silver in tissue, “may differ substantially” between silver nanomaterials and other forms of silver.  As one industry group points out, these assumption are not well-founded.  Even so, the SAP concluded “most existing models are not appropriate for use with silver nanomaterials and will not accurately predict nanosilver exposure scenarios.” Significantly, the SAP used the absence of scientific data as justification for implementation of an onerous and costly testing regime that may deter FIFRA nanopesticide registrants.  

The broader context of EPA's actions may give one pause about the agency's intentions for nanotechnology.  Among other things, EPA has recently been very secretive about its nanotechnology agenda.  For example, it refused my interview request after I said I intended to ask questions regarding the new scientific basis for its policy shifts.  Apparently, EPA is not coordinating with the other federal agencies in the NNI.  Also, EPA has removed the minutes of the SAP silver nanomaterials meeting from its website.

EPA's conduct is particularly disturbing in light of the “leaked” suggestion the agency may require any pesticide registrant who is aware that some constituent of a registered pesticide product is nanosized to report under FIFRA Section 6(a)(2), and its “coming determination” that substitution of a nanoscale active or inert ingredient for a conventionally-sized active or inert ingredient in a product currently registered under FIFRA requires an application to amend the registration, seem to indicate EPA is aligning with radical anti-technology groups.  At this point, the scientific justification for this alignment is frankly difficult to discern. 

Is EPA Going Its Own Way On Nanotech?

As I noted here, EPA's leadership has targeted the nanotechnology industry for regulation.  The Agency's December Action Initiation List reflects this, stating EPA is developing a significant new use rule under TSCA section 5(a)(2) "for nanoscale materials."  The rule will require "persons who intend to manufacture, import, or process" nanomaterials to "notify EPA at least 90 days before commencing that activity" so EPA may "prohibit or limit that activity before it occurs" to prevent "unreasonable risk to human health or the environment." 

EPA's intentions, particularly given the massive methodological and data quality problems of nanomaterial risk assessment, need to be better understood.  Inter-agency coordination between EPA and the rest of the Federal Government on nanotechnology regulation should be a priority, yet it seems EPA is moving forward without substantive consultation.  As a first step, the industry should request more transparency from the Agency, especially with respect to the data it relies on to support this regulatory initiative.